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Safety and PK of MBX-400 (Cyclopropavir) in Normal Volunteers
NCT02454699 · View on ClinicalTrials.gov ↗
Study Summary
This is a phase I safety, PK and food effect study of the CMV drug. In part 1 of the study, subjects will receive one of four dosage strengths of MBX-400 (100 mg once daily, 350 mg once daily; 750 mg once daily; and 1000 once daily) for 7 days and safety and PK will be assessed. Subjects must be 18 to 65 years of age, male or female; if female, be surgically-sterilized or post-menopausal; if male, have undergone vasectomy; have a body mass index (BMI) of 18 to 32 kg/m\^2; not be a user of nicotine-containing products; be willing to abstain from nicotine-containing products, alcohol and illicit drugs during the study. Subjects will be followed for 28 days post dosing.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG MBX400
Study Locations (1)
Georgia
- Emory Vaccine Center - The Hope Clinic — Decatur
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2015-11-10 |
| Est. Completion | 2017-12-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02454699
The ClinicalTrials.gov registry entry for NCT02454699 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Cytomegalovirus Infection appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02454699 reports 1 study location spanning 1 distinct geographic area — top geographies include Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02454699 about?
NCT02454699 is a clinical study titled "Safety and PK of MBX-400 (Cyclopropavir) in Normal Volunteers". This is a phase I safety, PK and food effect study of the CMV drug. In part 1 of the study, subjects will receive one of four dosage strengths of MBX-400 (100 mg once daily, 350 mg once daily; 750 mg once daily; and 1000 once daily) for 7 days and safety and PK will be assessed. Subjects must be 18 ...
What is the current status of trial NCT02454699?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2015-11-10. Estimated completion is 2017-12-01.
What conditions does trial NCT02454699 study?
This clinical trial studies the following conditions: Cytomegalovirus Infection. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02454699?
The interventions under investigation include: Placebo (OTHER), MBX400 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02454699?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02454699 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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